Updates in Relapsing Multiple Sclerosis (MS)

Estimates over 17 years suggest that the prevalence of MS in the U.S. ranges from 851,749 to 913,925 people, based on health claims data. Please keep in mind these are estimates and not exact.i While researchers have yet to produce a cure, there are various treatment options available to patients living with relapsing MS. Since the severity and specific symptoms of the disease vary from person to person, it is important for patients and doctors to have options when considering treatment.

In October, the U.S. Food and Drug Administration approved VUMERITY® (diroximel fumarate), a pill to treat relapsing MS. VUMERITY is available in the U.S.

“As a neurologist, selecting an appropriate treatment for relapsing MS with my patients is a key goal. The availability of VUMERITY offers another useful option for people living with relapsing MS,” stated Dr. Barry Singer, director and founder of The MS Center for Innovations in Care at Missouri Baptist Medical Center in St. Louis.

While the cause of relapsing MS is unknown, symptoms are thought to be due to the immune system’s attack on the protective sheath covering nerve fibers (myelin). This disrupts the flow of information between a person’s brain and the rest of their body. When your brain can’t properly communicate with nerves and muscles, various symptoms of relapsing MS can occur. MS is at least two to three times more common in women compared to men, and is most often diagnosed between the ages of 20 and 50.ii

If you have relapsing MS, or believe you may have relapsing MS, talk with your doctor about whether VUMERITY is right for you. Visit VUMERITY.com for more information.

Consumer Indication and Important Safety Information

VUMERITY® (diroximel fumarate)

What is VUMERITY® (diroximel fumarate)?

VUMERITY is a prescription medicine used to treat people with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults

It is not known if VUMERITY is safe and effective in children

Important Safety Information Do not take VUMERITY if you:

have had an allergic reaction (such as welts, hives, swelling of the face, lips, mouth or tongue, or difficulty breathing) to diroximel fumarate, dimethyl fumarate, or any of the ingredients in VUMERITY

Before taking and while you take VUMERITY, tell your healthcare provider about all of your medical conditions, including if you:

have liver problems

have kidney problems

have or have had low white blood cell counts or an infection

are pregnant or plan to become pregnant. It is not known if VUMERITY will harm your unborn baby

are breastfeeding or plan to breastfeed. It is not known if VUMERITY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using VUMERITY

Tell your healthcare provider about all the medicines you take including prescription and over-the- counter medicines, vitamins, and herbal supplements.

What should I avoid while taking VUMERITY?

Do not drink alcohol at the time you take a VUMERITY dose

What are the possible side effects of VUMERITY? VUMERITY may cause serious side effects including:

allergic reaction (such as welts, hives, swelling of the face, lips, mouth or tongue, or difficulty breathing). Stop taking VUMERITY and get emergency medical help right away if you get any of these symptoms

PML (progressive multifocal leukoencephalopathy) a rare brain infection that usually leads to death or severe disability over a period of weeks or months. Tell your healthcare provider right away if you get any of these symptoms of PML:

decreases in your white blood cell count Your healthcare provider should do a blood test to check your white blood cell count before you start treatment with VUMERITY and while you are on therapy. You should have blood tests after 6 months of treatment and every 6 to 12 months after that

liver problems. Your healthcare provider should do blood tests to check your liver function before you start taking VUMERITY and during treatment if needed. Tell your healthcare provider right away if you get any of these symptoms of a liver problem during treatment

severe tiredness

loss of appetite

pain on the right side of your stomach

have dark or brown (tea color) urine

yellowing of your skin or the white part of your eyes

The most common side effects of VUMERITY include:

flushing, redness, itching, or rash

nausea, vomiting, diarrhea, stomach pain, or indigestion

Flushing and stomach problems are the most common reactions, especially at the start of therapy, and may decrease over time. Taking VUMERITY with food (avoid high-fat, high-calorie meal or snack) may help reduce flushing. Call your healthcare provider if you have any of these symptoms and they bother you or do not go away. Ask your healthcare provider if taking aspirin before taking VUMERITY may reduce flushing

These are not all the possible side effects of VUMERITY. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov.